Fulvestrant

Generic Name
Fulvestrant
Brand Names
Faslodex, Fulvestrant Mylan
Drug Type
Small Molecule
Chemical Formula
C32H47F5O3S
CAS Number
129453-61-8
Unique Ingredient Identifier
22X328QOC4
Background

Fulvestrant is a drug treatment of hormone receptor (HR)-positive metastatic breast cancer in post-menopausal women with disease progression following anti-estrogen therapy. It is an estrogen receptor antagonist with no agonist effects, which works both by down-regulating and by degrading the estrogen receptor. While it is used as monotherapy for the treatment of breast cancers, it is also used in combination with alpelisib for the treatment of HR-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer

Indication

For the treatment of hormone receptor positive metastatic breast cancer in postmenopausal women with disease progression following anti-estrogen therapy, as monotherapy or in combination with other antineoplastic agents.

Associated Conditions
Advanced Breast Cancer, Advanced or Metastatic Breast Cancer
Associated Therapies
-

Examination of Breast Cancer Cells of Pre-menopausal and Post-menopausal Women Before and After Exposure to Tamoxifen or Fulvestrant.

Phase 1
Terminated
Conditions
Interventions
First Posted Date
2016-10-18
Last Posted Date
2021-05-19
Lead Sponsor
Icahn School of Medicine at Mount Sinai
Target Recruit Count
2
Registration Number
NCT02936206
Locations
🇺🇸

Mount Sinai West, New York, New York, United States

🇺🇸

Mount Sinai St. Luke's, New York, New York, United States

🇺🇸

Icahn School of Medicine at Mount Sinai, New York, New York, United States

Treatment of Metastatic Breast Cancer With Fulvestrant Plus Palbociclib or Tamoxifen Plus Palbociclib

First Posted Date
2016-09-23
Last Posted Date
2021-07-26
Lead Sponsor
Shannon Puhalla
Target Recruit Count
7
Registration Number
NCT02913430
Locations
🇺🇸

Magee-Womens Hospital UPMC, Pittsburgh, Pennsylvania, United States

Estrogen Receptor Antagonist in Patients With Pulmonary Arterial Hypertension

Phase 2
Completed
Conditions
Interventions
First Posted Date
2016-09-22
Last Posted Date
2019-12-09
Lead Sponsor
University of Pennsylvania
Target Recruit Count
5
Registration Number
NCT02911844
Locations
🇺🇸

University of Pennsylvania, Philadelphia, Pennsylvania, United States

Fulvestrant 500mg in Patients With Advanced Breast Cancer

First Posted Date
2016-09-21
Last Posted Date
2022-04-20
Lead Sponsor
Fudan University
Target Recruit Count
500
Registration Number
NCT02909361
Locations
🇨🇳

Fudan University Cancer Hospital, Shanghai, China

Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant

First Posted Date
2016-09-09
Last Posted Date
2023-03-13
Lead Sponsor
iOMEDICO AG
Target Recruit Count
388
Registration Number
NCT02894398
Locations
🇩🇪

Research Site, Wilhelmshaven, Germany

Alisertib With or Without Fulvestrant in Treating Patients With Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer

First Posted Date
2016-08-09
Last Posted Date
2024-10-18
Lead Sponsor
Mayo Clinic
Target Recruit Count
96
Registration Number
NCT02860000
Locations
🇺🇸

Georgetown University Medical Center, Washington, District of Columbia, United States

🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

🇺🇸

University of Michigan, Ann Arbor, Michigan, United States

and more 5 locations

Bioequivalence Study of Fulvestrant Injection 50 mg/mL in Healthy Post-menopausal Female Subjects

Phase 1
Completed
Conditions
Interventions
First Posted Date
2016-06-09
Last Posted Date
2017-03-09
Lead Sponsor
Fresenius Kabi
Target Recruit Count
266
Registration Number
NCT02795039
Locations
🇨🇦

BioPharma Services Inc., Toronto, Ontario, Canada

🇨🇦

Algorithme Pharma Inc., Mount Royal, Quebec, Canada

🇨🇦

Lambda Therapeutic Research Inc., Toronto, Ontario, Canada

A Study of Investigational Drug CFI-402257 in Patients With Advanced Solid Tumors

Phase 1
Active, not recruiting
Conditions
Interventions
First Posted Date
2016-06-07
Last Posted Date
2024-01-17
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
52
Registration Number
NCT02792465
Locations
🇨🇦

BC Cancer Agency, Vancouver, British Columbia, Canada

🇨🇦

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

🇨🇦

The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada

Pembrolizumab, Endocrine Therapy, and Palbociclib in Treating Postmenopausal Patients With Newly Diagnosed Metastatic Stage IV Estrogen Receptor Positive Breast Cancer

First Posted Date
2016-05-20
Last Posted Date
2024-10-30
Lead Sponsor
City of Hope Medical Center
Target Recruit Count
47
Registration Number
NCT02778685
Locations
🇺🇸

City of Hope Corona, Corona, California, United States

🇺🇸

City of Hope Medical Center, Duarte, California, United States

🇺🇸

City of Hope Antelope Valley, Lancaster, California, United States

and more 4 locations

A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer

First Posted Date
2016-05-05
Last Posted Date
2024-12-09
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
463
Registration Number
NCT02763566
Locations
🇧🇷

Fundação Pio XII - Hospital de Câncer de Barretos, Barretos, Sao Paulo, Brazil

🇨🇳

Jilin Province Tumor Hospital, Chang Chun, Ji Lin, China

🇨🇳

Liaoning Cancer Hospital&Institute, Shenyang, Liaoning, China

and more 42 locations
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